Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
115 participants
INTERVENTIONAL
2018-01-10
2022-08-31
Brief Summary
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In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks.
Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.
All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
OBE022 plus atosiban:
OBE022 will be given orally from Day 1 to Day 7. OBE022 treatment will be initiated ideally simultaneously or at a maximum within 24 h after atosiban start.
* Loading dose: 1 000 mg on Day 1.
* Maintenance dose on Day 1: 500 mg in the evening if loading dose was administered in the morning. If loading dose was administered in the afternoon, then the next dose will take place on the morning of Day 2.
* Maintenance dose from Day 2 to Day 7: 500 mg twice a day (only morning dose on Day 7)
Atosiban will be administered over 48h as per label.
OBE022
Oral
Atosiban
I.V.
Placebo
OBE022 matching placebo plus atosiban:
OBE022 matching placebo administration will follow the same regimen as the active group.
Atosiban will be administered over 48h as per label.
Placebos
Oral
Atosiban
I.V.
Interventions
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OBE022
Oral
Placebos
Oral
Atosiban
I.V.
Eligibility Criteria
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Inclusion Criteria
* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 28 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour
Part B
* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 24 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour
* ≥4 uterine contractions per 30 minutes
* Cervical dilatation of 1 to 4 cm inclusive
* At least one of the following signs of preterm labour:
1. positive IGFBP-1 or fœtal Fibronectin test
2. cervical length ≤ 25mm
3. progressive cervical change
Exclusion Criteria
* Oligohydramnios
* Known pathological Doppler ultrasound of the umbilical artery
* Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:
1. Premature rupture of membranes
2. Evidence or suspicion of abruptio placenta
3. Signs and/or symptoms of chorio-amnionitis
4. Pre-eclampsia, eclampsia or HELLP-syndrome
* Use of cervical cerclage in the current pregnancy or a pessary in situ
* Current use of anti-hypertensive medication
* Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions
18 Years
FEMALE
No
Sponsors
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Scope International AG
INDUSTRY
Iqvia Pty Ltd
INDUSTRY
Cytel Inc.
INDUSTRY
PhinC Development
INDUSTRY
ObsEva SA
INDUSTRY
Responsible Party
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Locations
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Gynekologicko-porodnická klinika Fakultní nemocnice Brno
Brno, , Czechia
Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze
Prague, , Czechia
Ústav pro péči o matku a dítě
Prague, , Czechia
Helsinki Universisty Hospital
Helsinki, , Finland
Hilel Yafe Medical Center, Maternal Fetal Unit
Haifa, , Israel
Rambam Medical Center, Maternal Fetal Unit
Haifa, , Israel
Meir Medical Center, Obstetrics and Gynecology Department
Kfar Saba, , Israel
Rabin Medical Center, Fetal-Maternal Medicine, Helen Schneider's Hospital for Women
Petah Tikva, , Israel
Moscow Regional Perinatal Center
Balashikha, , Russia
Kazan State Medical University
Kazan', , Russia
City clinical hospital № 15 named after O. M. Filatov of Healthcare Department of Moscow
Moscow, , Russia
Perinatal center of the City Clinical Hospital #24
Moscow, , Russia
Hospital La Paz
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hanoi Obstetrics and Gynecology Hospital
Hanoi, , Vietnam
My Duc Hospital
Ho Chi Minh City, , Vietnam
Countries
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References
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Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Other Identifiers
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17-OBE022-003
Identifier Type: -
Identifier Source: org_study_id
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